# Kallestad Diag, A Div. of Erbamont, Inc.

- Location (FDA's records): Chaska, MN
- FDA decisions: 58 (1987–1991): 58 510(k) clearances
- Product codes: DCF (4), LJC (4), GTQ (3), DHR (3), DCN (2), DEW (2), DFC (2), LIO (2), LJP (2), JIX (2), MSJ (2), JJQ (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Diagnostic Hybrids, Inc.: 1 (https://510kreport.com/company/diagnostic-hybrids)

## Its most-cited devices
- K864663: Pathfinder Chlamydia Culture Confirmation System (1987), cited by 1

## Recent decisions
- K910886: QM300 Antistreptolysin O (Aso) Antigen Pack (Jun 17, 1991)
- K910885: QM300 Calibrator G Pack (Jun 17, 1991)
- K910887: QM300 Control G Pack (Jun 17, 1991)
- K904725: Chlamydia System Software (CSS) (Jan 14, 1991)
- K902253: Pathfinder (TM) Chlamydia Microplate Kit (Jul 26, 1990)
- K902462: Modified QM300 Rheumatoid Factor Test (Jun 21, 1990)
- K900010: NDS Cortisol Test Kit and NDS Cortisol Calibrator (Apr 3, 1990)
- K900009: NDS Theophylline Test Kit & NDS TDM Calibrator Set (Mar 29, 1990)

Source page: https://510kreport.com/company/kallestad-diag-a-div-of-erbamont
